Understanding FDA 483 Observations and Their Impact on Pharmacies
When choosing a pharmacy for your prescription needs, most customers prioritize factors such as cost, convenience, and customer service. However, one crucial consideration that often goes overlooked is the pharmacy’s compliance with FDA regulations—specifically, whether it has received an FDA Form 483 Observation. Understanding what a 483 Observation is and why it matters can help customers make informed decisions about their healthcare providers.
Update on Tirzepatide Shortage: Or is There One?
Per the mutually agreed upon motion filed on October 11, 2024, the Food and Drug Administration (“FDA”) and the Outsourcing Facilities Association (“OFA”) agreed to file a joint status report to the court updating on their progress on reconsidering whether Tirzepatide was in shortage by November 21, 2024.
The Current State of Tirzepatide, What We Learned
On October 2, 2024, roughly two weeks ago the FDA posted on their website that Tirzepatize was no longer in shortage. This, as you can imagine, created widespread panic and uncertainty with all those involved in medical weight loss including the most important, the patients. Then on October 7, 2024, the Outsourcing Facilities Association of North America on behalf of its members along with Custom Laboratories (Plaintiffs) sued the Food and Drug Administration (Defendant) seeking Injunctive Relief in Federal Court in the Northern District of Texas. The Plaintiffs were asking for the Federal Court to enjoin the FDA from enforcement action as it relates to 503B Outsourcing Facilities. In plain language, the Plaintiffs wanted the FDA to stop any action against outsourcing facilities from producing an essential copy of Tirzepatide under the Food and Drug Cosmetic Act.